CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 147 enrolled
Drug / intervention
Doravirine 100 Mg +3 moredrug
Likely dose
Doravirine 100 Mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04636437
NCT04636437Phase 4Completed

Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Nov 19, 2020·Updated Jul 2, 2025

In Brief

A Phase 4 clinical trial evaluating Doravirine 100 Mg, Integrase strand transfer inhibitors, and 2 other interventions for HIV Infections. Completed, enrolled 147 participants across 27 sites.

Detailed Summary

The purpose of this study was to determine if people with HIV and obesity taking an antiretroviral treatment regimen containing an integrase strand transfer inhibitor (INSTI) with (tenofovir alafenamide/emtricitabine (TAF/FTC) would either slow their rate of weight gain, or even lose weight, over the span of about 1 year after a switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication) combined with either TAF/TFC or tenofovir disoproxil fumarate (TDF)/FTC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedNov 19, 2020
Enrollment StartJul 27, 2021
Primary CompletionOct 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.6 years ago

Interventions

Doravirine 100 Mgdrug

Participants received a 100 mg tablet by mouth daily with or without food.

Integrase strand transfer inhibitorsdrug

INSTIs were acquired through the standard of care locally.

Tenofovir alafenamide/emtricitabinedrug

NRTIs (TAF/FTC) were acquired through the standard of care locally.

tenofovir disproxil fumarate/emtricitabinedrug

NRTIs (TDF/FTC) were acquired through the standard of care locally.